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OpenTrials
Completed

NCT Number: NCT01582113

Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

To determine the functional effects of Citicoline, a natural supplement, when administered for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The investigators hypothesize that citicoline will provide cognitive benefits to this population after 28 days of supplementation.

Completed

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Key information

Conditions

Neurocognitive Improvement

Age range

13 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

The Brain Institute, University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age 13-18 years old
  • No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial

Exclusion criteria

  • Head injury with LOC > 5 minutes
  • Use of any psychotropic medication

Treatment and study plan

Citicoline

Drug

Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 500 mg or 250 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.

Other names: Cognizin Citicoline

Microcrystalline Cellulose

Other

Microcrystalline Cellulose will be the placebo administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.

Primary outcomes

  1. Neurocognitive performance

    Time frame: 28 days

    Using baseline assessment measures gathered at Visit 1, assessments collected at Visits 2 and 3 will be used to determine whether the combined administration of citicoline will improve neurocognitive performance in male adolescents.

Sponsors and collaborators

Lead sponsor

Deborah Yurgelun-Todd

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2012
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.